Danish EPA Publishes Proposal for Technical Information Requirements for Nanomaterials

The Danish Environmental Protection Agency (EPA) published on March 20, 2013, a proposal for technical information requirements for nanomaterials. The Danish EPA states that its proposal may be used in legislation concerning nanomaterials, such as the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The Danish EPA reviewed information requirement recommendations from expert groups, associations, and authorities. According to the Danish EPA, the proposed information requirement scheme is based on the REACH methodology, i.e., a stepwise approach requiring more information at higher tonnage levels. The Danish EPA notes that the proposal “should not necessarily be seen as a proposal for updating REACH, as it could also be put forward as a stand-alone scheme for nanomaterials and used in relation to adapting other existing legislation, or it could be used for guiding.”

The proposed stepwise information requirement scheme consists of four tonnage levels that could correspond to the REACH tonnage trigger levels or be lowered. The proposal includes a number of “new” information requirements as compared to those for non-nanoscale materials, most of which relate to the description/characterization of nanomaterials and other physicochemical properties. For a number of existing information requirements, the proposal would adapt the endpoints and/or modify the adaptation rules. The proposal reviews more general issues that the Danish EPA states “should be addressed in relation to a regulatory testing requirements scheme for nanomaterials, possibly in the legislation itself, but certainly in guidance.”

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